Three departments jointly issued a document! Trial plan for temporary import of clinically urgently needed drugs and medical devices in Shanghai

Notice on the Formulation and Issuance of the “Shanghai Work Plan for Guiding the Temporary Import of Clinically Urgently Needed Drugs and Medical Devices (Trial)” by the Shanghai Municipal Drug Administration, Shanghai Municipal Health Commission, and Shanghai Customs.

Ⅰ. Work measures

i. Establishment of a working mechanism for temporary import services

(i)Local medical institutions that meet the application requirements may, based on actual clinical conditions, submit requests for the temporary import of clinically urgently needed drugs to the Shanghai Municipal Drug Administration (hereinafter referred to as the Municipal Drug Administration) and the Shanghai Municipal Health Commission (hereinafter referred to as the Municipal Health Commission); for requests for the temporary import of clinically urgently needed medical devices, they shall submit separately to the Municipal Drug Administration. The Municipal Health Commission and the Municipal Drug Administration shall, in accordance with their duties, guide medical institutions in preparing application materials.Medical institutions can, based on clinical needs and on legal working days, submit requests for the temporary import of clinically urgently needed drugs and consult on material applications to the Municipal Drug Administration (consultation hotline: 021-63269368) and the Municipal Health Commission (consultation hotline: 021-23117857), and submit requests for the temporary import of clinically urgently needed medical devices and consult on material applications to the Municipal Drug Administration (consultation hotline: 021-63269368).

(ii)Medical institutions prepare application materials in accordance with the “Work Plan for Temporary Import of Clinically Urgently Needed Drugs” (hereinafter referred to as the “Work Plan”) and the “Management Requirements for the Temporary Import and Use of Clinically Urgently Needed Medical Devices by Medical Institutions” (hereinafter referred to as the “Management Requirements”), which were jointly formulated and issued by the National Health Commission (hereinafter referred to as the National Health Commission) and the National Medical Products Administration (hereinafter referred to as the National Medical Products Administration).

(iii)For drugs that are temporarily imported as clinically urgently needed drugs, after receiving the application materials, the Municipal Health Commission shall, under the guidance of the National Health Commission, organize an argumentation, form a written assessment opinion on matters such as whether the applying medical institution has the ability to use and manage the drug, whether the drug is clinically urgently needed, and whether the demand is reasonable, and report it to the National Health Commission.

（iv） For those that fall under the temporary import of medical devices urgently needed for clinical use, after receiving the application materials, the municipal drug regulatory authority, under the guidance of the National Medical Products Administration, will conduct an early assessment and guidance on whether the applying medical institution has the ability to use and manage the devices, whether the medical devices are urgently needed for clinical use, and whether the quantity used is reasonable, and put forward assessment opinions.

（v） The Municipal Drug Administration, the Municipal Health Commission, and the Shanghai Customs District of the People’s Republic of China (hereinafter referred to as Shanghai Customs) shall establish an information exchange mechanism to promptly notify each other of the approval status of clinically urgently needed drugs and medical devices by the National Medical Products Administration, thereby accelerating the import customs clearance of drugs and medical devices.

ii. Simplification for the evaluation for non-first-time imports

（i） For medical institutions applying again for the temporary import of clinically urgently needed drugs, if the applied variety remains unchanged, the initial evaluation opinions can be used, and if necessary, only the applied quantity needs to be evaluated.

ii. For medical devices that are temporarily imported due to urgent clinical needs, if after their use, they need to continue to be used or the quantity used needs to be increased because other patients have urgent clinical needs, and the medical institution using them remains unchanged, the initial joint evaluation opinion can be reused. If necessary, only the applied quantity needs to be evaluated.

（III）Enhancing customs clearance facilitation

Medical institutions can, based on the approval of imported drugs by the National Medical Products Administration and in combination with clinical needs, apply to the municipal drug regulatory authority in batches for the “Imported Drug Customs Clearance Form”.This type of imported drug does not require customs clearance inspection. The Municipal Drug Administration shall issue the “Customs Clearance Form for Imported Drugs” within one working day, and Shanghai Customs shall assist in accelerating the customs clearance procedures.

Medical institutions purchase corresponding medical devices through medical device operating enterprises. Medical device operating enterprises apply for import customs clearance with the approval of the National Medical Products Administration, and Shanghai Customs assists in accelerating the clearance procedures.

Ⅱ. Safeguard measures

i. Strengthening organizational coordination

The Municipal Drug Administration, together with the Municipal Health Commission, shall establish  a working mechanism for the temporary import service of clinically urgently needed drugs and medical devices, and is responsible for overall planning, coordination, and promotion. The Municipal Drug Administration guides medical institutions in formulating systems for reporting and monitoring adverse reactions to temporarily imported drugs and systems for monitoring adverse events of temporarily imported medical devices, and supervises their implementation. The Municipal Health Commission guides medical institutions to formulate clinical technical specifications in accordance with the “Regulations on Pharmaceutical Affairs Management in Medical Institutions”, do a good job in the management of the use of pharmaceuticals and medical devices, prevent abuses, and carry out relevant work in accordance with their responsibilities.

ii. Strengthening utilization management

Medical institutions and drug/medical device operators bear the risk responsibility for the quality and safety of temporarily imported drugs/medical devices in accordance with the law.Medical institutions shall strengthen the management of the use of temporarily imported medicines and medical devices in accordance with the relevant provisions of the “Work Plan” and “Management Requirements”.First, the development of clinical specifications, clear clinical diagnosis and treatment of the use of drugs and equipment, patient groups, the use of departments and the list of doctors, and strictly regulate the behavior of physicians with drugs and equipment; second, the development of improved safety precautions and risk monitoring and disposal of plans; third, the establishment of a sound quality management system, with temporary imported drugs and equipment in line with the requirements of the storage and protection of the conditions; fourth, to do a good job in fully informing the work of the informed consent in writing, the use of medical records and other relevant data and information related to the use of medicines and devices are preserved for a long period of time; fifthly, the assessment and evaluation work is done well, and the use of medicines and devices is reported to the Municipal Health and Health Commission on an annual basis and copied to the Municipal Bureau of Drug Supervision; sixthly, the monitoring of adverse reactions of the use of medicines and devices is done well, and the occurrence of serious adverse reactions/events directly related to medicines and devices or the discovery of hidden quality and safety risks should be discontinued immediately, and the immediate report of the Municipal Drug Administration, Municipal Health Commission and Shanghai Customs.

iii. Strengthening policy advocacy

The Municipal Drug Administration, in conjunction with the Municipal Health and Wellness Commission and other departments, will strengthen policy publicity by carrying out policy presentations, field research and other ways to collect the needs of medical institutions for temporary importation in a timely manner, and do a good job of summarizing the list of temporarily imported varieties as well as summarizing the experience of the results achieved, so as to provide better services and promote the temporary importation of urgently needed medicines and equipment for the clinical needs of the city, and to further enhance the accessibility of medicines and equipment for clinical use in the city to the benefit of the patients

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Source：Shanghai Municipal Drug Administration
Translated & edited：Bradyknown